InjuryGAS
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jun 5, 2012 · Event occurred Jun 6, 2011
Report 2210968-2012-01975 · MDR key 2598422
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, IncModel number
NACatalog number
NI
Lot number
NI
Product problems
- Break
Patient
62 YR
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REPAIR OF THE DELTOID LIGAMENT ON (B)(6), 2011 AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE BROKE. THE NEEDLE FRAGMENT REMAINS IN THE BONE. ADDITIONAL INFORMATION REQUESTED.
Additional Manufacturer Narrative
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MEDWATCH REPORT (B)(4).
Remedial action
- Other